CN115025162B - 一种复方茶油烧伤药膏的制备方法 - Google Patents
一种复方茶油烧伤药膏的制备方法 Download PDFInfo
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- CN115025162B CN115025162B CN202210679066.2A CN202210679066A CN115025162B CN 115025162 B CN115025162 B CN 115025162B CN 202210679066 A CN202210679066 A CN 202210679066A CN 115025162 B CN115025162 B CN 115025162B
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Abstract
本发明涉及一种复方茶油烧伤药膏的制备方法，步骤如下：将地榆、紫草、积雪草、虎杖、黄连、黄柏、生地、冰片按比例添加混合、研磨成粉、过300目筛并添加于茶油中。将蜂蜡按一定的比例与茶油混合，通过热溶冷凝的方式制备复方药膏。本发明以绿色、天然、无毒、环境友好的蜂蜡以及单硬脂酸甘油酯（GMS）为凝胶剂，协同构建具有优越稳定性的凝胶网络结构。该方法制备工艺简单、成本低廉、使用方便，制备过程对无菌环境和无菌操作无要求。同时，本发明中所用中药材皆具有杀菌、抗炎、清热止痛、消肿敛疮等作用，诸药配伍能使创面愈合更快，增强局部组织的抗菌能力，可治疗轻度烧伤。
Description
技术领域
本发明涉及一种复方茶油烧伤药膏的制备方法。
背景技术
烧伤烫伤属于生活中常见的意外伤害，常由于开水、沸油、火、酸碱等对人体皮肤作用而造成复杂的皮肤疾病。Ⅰ度烧伤或烫伤只伤及表皮层，能致皮肤发红、肿胀，但无水泡现象；Ⅱ度烧烫伤伤及真皮层，使皮肤局部发生红肿、发热、疼痛、并有明显的水泡；Ⅲ度烧烫伤为重度烧烫伤，能伤及肌肉组织、骨骼及神经细胞，造成皮肤焦黑、坏死，产生剧烈疼痛。遇烧烫伤，若不及时处理，则会引发感染，产生疤痕，影响肢体功能。
目前，市面上用于治疗烧烫伤的药物，多以中草药为主，即将多味中药研磨成粉，与结构化剂混合，制成膏剂。然而，该类药膏虽成分单一，制作简易，但其消肿、止痛、生肌效果缓慢，愈合时间长，疤痕明显。
发明内容
本发明要解决的技术问题是：提供一种复方茶油烧伤药膏的制备方法，该方法制备工艺简单、成本低廉、使用方便，能提高烧伤、烫伤的治疗效果，且制备过程对无菌环境和无菌操作无要求。
解决上述技术问题的技术方案是：一种复方茶油烧伤药膏的制备方法，包括如下重量组分：地榆0.1～25份，紫草0.2～30份，积雪草0.5～30份，虎杖1～35份，黄连0.1～25份，黄柏0.1～25份，生地1～25份，冰片0.1～5份。
包括如下制备步骤：
（a）称取0.5～15份蜂蜡，切片，研磨成粉，得蜂蜡粉末；
（b）按以上配比取地榆、紫草、积雪草、虎杖、黄连、黄柏、生地和冰片洗净，冷风干燥，研磨后过筛，制备复合药粉；
（c）将蜂蜡粉末与0.1～1.0份单硬脂酸甘油酯加入至80～100份茶油中，加热以溶解；再将复合药粉加入至茶油中，利用手持剪切均质机将复合药粉分散均匀得油相溶液，并将装有油相溶液的容器浸入冰水浴中直至油凝胶形成；
（d）将所得油凝胶置于紫外灯下杀菌消毒，得治疗烧伤的复方茶油药膏。
所述一种复方茶油烧伤药膏的制备方法，优选如下重量组分：地榆0.2～18份，紫草1～25份，积雪草2～25份，虎杖2～30份，黄连0.5～25份，黄柏0.5～22份，生地2～20份，冰片0.5～4份。
所述的一种复方茶油烧伤药膏的制备方法，优选如下重量组分：地榆1～16份，紫草5～20份，积雪草5～20份，虎杖5～25份，黄连1～20份，黄柏2～20份，生地5～18份，冰片1～3份。
进一步的，步骤（a）中，片状蜂蜡的规格为5 mm×10 mm。
进一步的，步骤（b）中，药粉过筛的具体操作是用300目筛网过滤3次。
进一步的，步骤（c）中加热溶解蜂蜡及单硬脂酸甘油酯的温度为50～70 ℃。
进一步的，步骤（c）中，剪切均质机的均质速率为5000～12000 rpm。
进一步的，步骤（b）中，冷风干燥的温度为10～20 ℃。
在本发明中，各组分的功效如下：
蜂蜡与单硬脂酸甘油酯（GMS）为本发明中茶油的结构化剂，可赋予茶油坚固的凝胶网络结构，使茶油在皮肤表面具有更强的附着性。GMS同时具备亲水基团与亲油基团，将其加入至茶油中可降低将油脂涂抹于皮肤而带来的不适感。同时，均匀分布于油凝胶的蜂蜡晶体也可延缓活性物质的释放，延长药效。不仅如此，蜂蜡中还含有类胡萝卜素、维生素A、芳香物质等成分，起到抗菌消炎的作用。
茶油作为本发明中的连续相，来源于融水苗族自治县，具有清热解毒，活血散瘀，止痛等功效，具有一定的药用价值。民间也不乏茶油防治少儿尿布疹及烧烫伤的应用。
地榆具有药食两用性，其根可入药。据古籍记载，地榆具有止血凉血、清热解毒、排脓、可用于调敷汤火伤，疳疮溃烂。
紫草具有凉血、活血、清热、解毒等功效，同时具备抗菌消炎的作用，能够有效抑制金黄色葡萄球菌、灵杆菌、化脓菌、大肠杆菌甚至是京科68-1病毒的生长。可用于治疗烧伤、湿疹等皮肤疾病。
积雪草味苦、性寒，具有清热利湿，解毒消肿的功效。临床上采用积雪草止血止痛、活血化瘀、治疗皮肤溃疡、促进皮肤生长及组织细胞增生。
虎杖又名苦杖，其根为黄色染料，亦可入药。具有活血化瘀、祛风利湿、散瘀定痛等功效。能够治疗水火烫伤、跌打损伤、痈肿疮毒等。
黄连性寒，味苦，含小檗碱、黄连碱、甲基黄连碱等有效成分，具有清热燥湿、泻火解毒的功效，适量外用，能够治疗湿疹、湿疮、流脓等。
黄柏又称黄檗，属芸香科芸香目，味苦，性寒，具有清热解毒，泻火燥湿等功效，外用可治疗治火烫伤、中耳炎、急性结膜炎等。
生地别名生地黄，野地黄等，属玄参科，含有β-谷甾醇与甘露醇等活性成分，具有清热生津、凉血、止血的功效，并兼具抗菌消炎的作用。
冰片又名龙脑、龙脑香等，尚含葎草烯、β-榄香烯、石竹烯等倍半萜，齐墩果酸、麦珠子酸、积雪草酸、龙脑香醇酮、龙脑香二醇酮、古柯二醇等三萜化合物，外用能清热消肿、止痒止痛，同时具备消炎抗菌的作用。
本发明以绿色、天然、无毒、环境友好的蜂蜡以及单硬脂酸甘油酯（GMS）为凝胶剂，协同构建具有优越稳定性的凝胶网络结构，通过热溶冷凝的方式制备复方药膏。同时，本发明中所用中药材皆具有杀菌、抗炎、清热止痛、消肿敛疮等作用，诸药配伍能使创面愈合更快，增强局部组织的抗菌能力，可治疗轻度烧伤。另外，由于本发明选用的中药材具有杀菌的功效，故在制备过程中不需要在无菌环境下进行无菌操作，即对制备环境无要求，更利于实际生产。
下面，结合实施例对本发明之一种复方茶油烧伤药膏的制备方法的技术特征作进一步的说明。
具体实施方式
实施例1
（a）称取5份蜂蜡，切片，规格为5 mm×10 mm左右，研磨成粉，得蜂蜡粉末。
（b）将地榆20份，紫草20份，积雪草25份，虎杖30份，黄连20份，黄柏20份，生地15份，冰片2份。洗净，10～15 ℃条件下冷风干燥，研磨后过筛，制备复合药粉。
（c）将蜂蜡粉末与0.2份GMS加入至100份茶油中，加热至60℃以溶解蜂蜡；将复合药粉加入至茶油中，利用手持剪切均质机（均质速率为10000 rpm）将药粉分散均匀，并将装有油相的容器浸入冰水浴中直至油凝胶形成。
（d）将所得油凝胶置于紫外灯下杀菌消毒，得可用于治疗烧伤的复方茶油药膏。
实施例2
（a）称取8份蜂蜡，切片，研磨成粉，得蜂蜡粉末；
（b）将地榆15份，紫草20份，积雪草25份，虎杖25份，黄连25份，黄柏20份，生地15份，冰片1份。洗净，13～18 ℃条件下冷风干燥，研磨后过筛，制备复合药粉。
（c）将蜂蜡粉末与1份GMS加入至80份茶油中，加热70℃以溶解蜂蜡；将复合药粉加入至茶油中，利用手持剪切均质机将药粉分散均匀，并将装有油相的容器浸入冰水浴中直至油凝胶形成。
（d）将所得油凝胶置于紫外灯下杀菌消毒，得可用于治疗烧伤的复方茶油药膏。
实施例3
（a）称取10份蜂蜡，切片，研磨成粉，得蜂蜡粉末；
（b）将地榆20份，紫草20份，积雪草20份，虎杖20份，黄连20份，黄柏20份，生地20份，冰片3份。洗净，15～20 ℃条件下冷风干燥，研磨后过筛，制备复合药粉。
（c）将蜂蜡粉末与0.5份GMS加入至90份茶油中，加热55℃以溶解蜂蜡；将复合药粉加入至茶油中，利用手持剪切均质机将药粉分散均匀，并将装有油相的容器浸入冰水浴中直至油凝胶形成。
（d）将所得油凝胶置于紫外灯下杀菌消毒，得可用于治疗烧伤的复方茶油药膏。
本发明各实施例所用茶油为融水苗族自治县出产的茶油。作为一种变换，也可以采用其它地区生产的茶油。
试用效果统计
1、治疗方法
48例实验者，均有不同程度皮肤Ⅰ、Ⅱ度烫伤。采用本发明实施例1制备的复方茶油药膏，取适量外用，用棉签涂抹于烫伤部位，使皮肤暴露。每日涂抹2-5次，7 日一个疗程。
2、疗效指标
痊愈：局部红肿，灼痛或水泡消失。
显效：局部红肿，灼痛或水泡减轻。
无效：治疗 3～5 天后症状无变化。
3、结果统计
本发明烧伤膏治疗48例烫伤患者，结果如下表所示，临床痊愈14例，显效30例，无效4例，总有效率91.7%。
4、本发明用于治疗烧伤的复方茶油药膏能明显治疗烫伤患者的局部红肿，灼痛或水泡等症状，未见不良反应。
典型病例
患者覃某，27岁，保姆，右手臂烫伤，皮肤红肿、出现水疱，疼痛感显著，外涂本发明实施例1制备的复方茶油药膏，每日3次，16小时后，疼痛感减轻，红肿减少，三日后疼痛消失，红肿退散。
患者韦某，24岁，汽车修理工，左手臂烫伤，皮肤红肿，水疱，有渗出物，外涂本发明实施例1制备的复方茶油药膏，每日3次，20小时后，疼痛感减轻，红肿减少，三日后水疱减少，疼痛消失，红肿退散。
Claims (5)
1.一种复方茶油烧伤药膏的制备方法，其特征在于：包括如下重量组分：地榆0.1～25份，紫草0.2～30份，积雪草0.5～30份，虎杖1～35份，黄连0.1～25份，黄柏0.1～25份，生地1～25份，冰片0.1～5份；
包括如下制备步骤：
（a）称取0.5～15份蜂蜡，切片，研磨成粉，得蜂蜡粉末；
（b）按以上配比取地榆、紫草、积雪草、虎杖、黄连、黄柏、生地和冰片洗净，冷风干燥，研磨后过筛，制备复合药粉；
（c）将蜂蜡粉末与0.1～1.0份单硬脂酸甘油酯加入至80～100份茶油中，加热以溶解；再将复合药粉加入至茶油中，利用手持剪切均质机将复合药粉分散均匀得油相溶液，并将装有油相溶液的容器浸入冰水浴中直至油凝胶形成；
（d）将所得油凝胶置于紫外灯下杀菌消毒，得治疗烧伤的复方茶油药膏；
步骤（c）中加热溶解蜂蜡及单硬脂酸甘油酯的温度为50～70℃；
步骤（c）中，剪切均质机的均质速率为5000～12000 rpm；
步骤（b）中，冷风干燥的温度为10～20 ℃；
所述茶油为融水苗族自治县出产的茶油。
2.根据权利要求1所述的一种复方茶油烧伤药膏的制备方法，其特征在于：包括如下重量组分：地榆0.2～18份，紫草1～25份，积雪草2～25份，虎杖2～30份，黄连0.5～25份，黄柏0.5～22份，生地2～20份，冰片0.5～4份。
3.根据权利要求2所述的一种复方茶油烧伤药膏的制备方法，其特征在于：包括如下重量组分：地榆1～16份，紫草5～20份，积雪草5～20份，虎杖5～25份，黄连1～20份，黄柏2～20份，生地5～18份，冰片1～3份。
4. 根据权利要求1-3任一项所述的一种复方茶油烧伤药膏的制备方法，其特征在于：步骤（a）中，片状蜂蜡的规格为5 mm×10 mm。
5.根据权利要求1-3任一项所述的一种复方茶油烧伤药膏的制备方法，其特征在于：步骤（b）中，药粉过筛的具体操作是用300目筛网过滤3次。
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